FDA WARNING_LETTER - ByPro Nutrition LLC - August 17, 2022

The FDA issued a Warning Letter to Dr. Robert L. Bynum regarding the product Dodecin, following an inspection of the facility at 1906 Potomac Dr., Columbia, MO, from August 10-17, 2022. The FDA also reviewed the website www.bypronutrition.com in October, November 2022, and March 2023.

The FDA determined that claims on the Dodecin product label and website establish it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] due to its intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims were found on the product label, various pages of the website (Order Now, Dodecin’s Ingredients, Dodecin Benefits, Dodecin FAQs), and a YouTube video linked to the homepage. Personal testimonials on the website also supported this intended use.

Dodecin is considered an "unapproved new drug" under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for its stated uses and lacks prior FDA approval. Introducing or delivering such a product into interstate